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1Department of Internal Medicine, Carver College of Medicine,2Department of Health and Human Physiology, UI College of Liberal Arts and Sciences,3Department of Neurology, Carver College of Medicine, 4Department of Biostatistics, College of Public Health, University of Iowa, 5Department of Extended Care and Rehabilitation Service Line, Iowa City VA Health Care System, Iowa City, IA, USA

Purpose: To investigate the effects of a multimodal intervention including a modified Paleolithic diet, nutritional supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation and massage on walking performance and balance of subjects with progressive multiple sclerosis (MS).

Materials and methods: Twenty subjects with mean (standard deviation) age of 51.7 (6.4) years and Expanded Disability Status Scale score of 6.2 (1) participated in a 12-month study. Assessments were completed at baseline, 3, 6, 9, and 12 months.

Results: The entire cohort did not show significant changes in any of the assessments over 12 months except higher speed of walking toward the 10 feet mark during timed up and go (TUG) test at 6 months compared with baseline (mean change 7.9 cm/s [95% confidence interval {CI}]: 0.3, 15.2; p=0.041). Sub-group analysis revealed that 50% subjects (n=10) showed decrease in TUG time from baseline to at least 3 of 4 time-points post-intervention and were considered as responders (TUG-Res), the remaining 10 subjects were considered as nonresponders (TUG-NRes). Over 12 months, TUG-Res showed decreased mean TUG time by 31% (95% CI: −52%, −2%), increased median Berg Balance Scale scores (42 to 47), 30% increase in mean timed 25-foot walk speed (>20% considered clinically significant) and increased speed of walk toward 10 feet mark during TUG by 11.6 cm/s (95% CI: −3.0, 25.9) associated with increases in step lengths and decrease in step duration. TUG-NRes showed deterioration in walking ability over 12 months. Comparison of TUG-Res and TUG-NRes showed no significant differences in adherence to intervention but better stride duration and longer step length at baseline for TUG-Res than for TUG-NRes (p<0.05).

Conclusion: A multimodal lifestyle intervention may improve walking performance and balance in subjects with progressive MS who have mild-to-moderate gait impairment, whereas subjects with severe gait impairments may not respond to this intervention. Future trials should assess effects of this intervention in subjects with MS during early stages of the disease.

Wednesday, July 5, 2017

Understanding and stopping MS in its tracks requires a better understanding of the role that the immune system plays in this disease. This system is involved both in the inflammatory attacks on myelin and, very possibly, in the injury to axons (the wire-like nerve fibers) that contributes to longer-term disability. Research on the immune system includes studies on:

Understanding components of the immune system such as T cells, B cells, and antibodies

Identifying new targets for therapeutic intervention while leaving the rest of the immune system capable of fighting infections

Identifying substances and processes involved in the injury of axons

Identifying the body’s natural immune messenger molecules that can either turn on or turn off immune attacks

Significant progress is being made in understanding the immune system's involvement in MS, which will help drive breakthrough solutions to change the world for everyone with MS.

We’re making progress

Studies of the immune system in MS laid the groundwork for every disease-modifying therapy now available, and these studies continue to hold promise for finding ways to stop MS. Here are reports of recent progress:

Decades of Basic Research Pay Off with Early Clinical Trial of Immune Therapy An international team has reported results of a small, early clinical trial involving 10 people with relapsing or secondary-progressive MS. The trial tested the feasibility and safety of using a patient’s own altered blood cells to reduce immune responses against specific components of myelin, the nerve covering that is a key target of immune attacks in MS. Treatment appeared safe and showed signs of reducing immune responses to myelin, This is one example of how the Society’s long-term investment in basic research that has relevance to MS pays off. Read details here.

Immune system may drive cognitive changes in MSMemory impairment and other cognitive changes are experienced by many people with MS, but the details of how this occurs are not clear. Now researchers supported in part by the National MS Society report evidence that a group of immune system proteins called “complement” may play a role in the loss of nerve connections (synapses) in the hippocampus, a part of the brain linked to memory. Read more

Distinguishing between 'good' and 'bad' immune cellsA team funded by the National MS Society has shed new light on immune cells known as macrophages, and how one type of these cells may play a significant role in launching damage in MS. The researchers have discovered a way to differentiate between good and bad types of these immune cells active during MS-like disease in mice, and if further research shows that these findings hold true for people with MS, this opens up possibilities for developing therapies that target the bad cells and spare the good cells. Read more

Just when I thought I had experienced every multiple sclerosis (MS) symptom possible, another one emerges: sciatic nerve pain. It can happen to anyone, but it is also associated with MS.

A couple of months ago, I woke up with a sharp knife-type pain on the upper back side of my left leg. All I could wonder was “What is MS doing to me now?”

Usually doing stretches while lying on my bed alleviated any sciatic nerve pain I had. I bent my left leg up to meet my chest, then lifted it over my body. Next I held my left foot with my right hand for about 20 seconds. Then I completed the move by stretching my leg out straight and flexing my foot.

I learned to live with sciatic pain. When it showed up, I did my stretches, or walked it off, but now it is moving in a whole new direction. The sciatic nerve, by the way, is the longest in the body, running from the lower back to the tops of the feet.

The other day I went to get up out of my chair, and had the worst burning pain in the same area where the sharp pain was. It felt as if someone were poking me with a red-hot poker! It attacks me every time I go to stand, and sometimes when I’m trying to sit.

A Multiple Sclerosis Society of New Zealand article, “Multiple Sclerosis and Pain,” written by Anne McAuley and by Dr. Rosemary White, explores a theory on what causes the sciatic pain in MS. The article says most pain with MS is due to immobility or poor posture instead of damaged nerves. The article says immobility, or sitting in a wheelchair for a long time, puts pressure on the nerves in the back of the legs that generates sciatic pain.

The contention that pain is related to immobility or poor posture sounds reasonable to me. In fact, I was sitting in my wheelchair for almost three hours before this week’s burning sensation appeared. Being in the wheelchair for that long was not the best scenario for me. I should have been in a regular chair, and moving around from time to time, instead of sitting that long.

Complementary therapies are alternative therapies used in addition to traditional treatments. For example, you may have weekly massages to complement your drug treatment.

What is recommended for MS?

Positive attitude. Having a positive outlook cannot cure MS, but it can reduce your stress and help you feel better.

Exercise. Exercises such as tai chi and yoga can lower your stress, help you to be more relaxed, and increase your energy, balance, and flexibility. As with any exercise program, check with your doctor before getting started.

Diet. It is important for people with MS to follow a healthy, well-balanced diet. Ask your doctor what diet is right for you.

What are some alternative/complementary therapy options for MS?

Massage. Many people with MS receive regular massage therapy to help relax and reduce stress and depression, which can exacerbate the disease. There is no evidence that massage changes the course of the disease. It is usually safe for people with MS to receive a massage, but if you have bone-thinning osteoporosis (usually as a result of your treatments), massage may be dangerous. Talk to your doctor first.

Acupuncture. Some people with MS report that acupuncture provides some relief of symptoms such as pain, muscle spasms, or bladder control problems. There have been no scientific studies to confirm this or to document that acupuncture is safe for people with MS. Also, keep in mind that there are always risks when a procedure involves puncturing the body with needles, as is done with acupuncture. The main risk is infection. Unless sterile techniques are used, acupuncture could transmit hepatitis or HIV.

Evening primrose oil (linoleic acid). Linoleic acid is also found in sunflower seeds and safflower oil. There is some evidence that taking an oral supplement of linoleic acid may slightly improve MS symptoms.

Diet. It is important for people with MS to maintain a healthy, well-balanced diet to keep them as healthy as possible. Discuss any dietary concerns you may have with your doctor.

Marijuana. The use of marijuana to treat any illness remains highly controversial. Some people with MS claim that smoking marijuana helps relieve spasticity and other MS-related symptoms. However, there is little evidence to date that marijuana really works. Research is ongoing to answer this important question. Until more is known, doctors do not recommend the use of marijuana to treat MS, as the drug is associated with serious long-term side effects such as heart attack or memory loss.

How can I tell which therapies are worth taking?

Alternative therapy can be helpful in many cases, but some treatments can be ineffective, costly, and even dangerous. The best way to evaluate your options is to become educated. Ask yourself the following questions:

The Human Endocannabinoid System & Your Health

What is the Endocannabinoid System?

The endocannabinoid (EC) system is a unique biological system which earned its name from the cannabis sativaplant that led to its discovery. The system plays an integral role in your overall physical and psychological health. It is comprised of three components:

Endogenous cannabinoids

Cannabinoid receptors

Metabolic enzymes

Though the EC system may serve different functions in different tissues, the overall goal of the entire endocannabinoid system is to achieve homeostasis, the body’s ability to maintain and regulate a stable internal environment despite ever-changing external conditions.

“ONE OF THE HARDEST THINGS FOR PEOPLE TO UNDERSTAND IS HOW MS IS COMPLETELY UNIQUE TO EACH INDIVIDUAL. NO TWO PEOPLE ARE THE SAME. AND THERE IS A HUGE SPECTRUM OF SEVERITY. I TELL PEOPLE THAT JUST BECAUSE THEY KNOW ME, DOESN'T MEAN THEY KNOW MS.”

Clinical trials can offer hope for many people and may help researchers find better treatments for others in the future.

A clinical trial is a research study in human volunteers that tests new ways to prevent, detect, diagnose or treat diseases. They help determine whether investigational vaccines, medicines, or new uses for existing medicines are safe and effective. Clinical trials are necessary to find potential medicines and vaccines that work to improve people’s health.

Clinical trials are also known as intervention studies, clinical studies or clinical research.

Phases of Clinical Trials

http://www.merck.com/clinical-trials/about-clinical-trials.html

Phase 1: Phase 1 clinical trials test the medicine or vaccine in a small group of 20 to 100 volunteers who are usually healthy, but not always. The trial often takes place in a hospital. The goals are to determine:

If the medicine or vaccine is safe

If there are any side effects

How the medicine is broken down by and discharged from the body

How much medicine is needed and how often

For a vaccine, researchers see if it causes the desired response from the body’s immune system

Phase 1 trials can take from six months to one year to complete.

Phase 2: Phase 2 clinical trials test the vaccine or medicine in approximately 100 to 500 volunteers. In the case of medicines, volunteers usually have the disease or condition the investigational medicine is designed to treat. In vaccine studies, the volunteers are usually healthy. The goals of this phase are to determine:

How well the medicine or vaccine works

If the medicine or vaccine is safe

If there are any side effects

How much of the medicine or vaccine is needed and how often

Phase 2 trials can take from six months to one year or more to complete.

Phase 3: Phase 3 clinical trials can test the medicine or vaccine in 1,000 to 5,000 patient volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices. Researchers closely monitor patients at regular intervals to:

Confirm that the medication or vaccine is effective

Identify and monitor side effects

Compare the medicine or vaccine to commonly used treatments

Phase 3 trials can take from one to four years to complete, depending on the disease, length of study and the number of volunteers.

Phase 4 or On-going trials: Phase 4 clinical trials are conducted after the medicine or vaccine has been approved by the appropriate government and regulatory agencies and is being marketed. Researchers continue to gather information about the medicine or vaccine and its safety, side effects and effectiveness.

Marketed products also are studied for new indications. Thousands of people usually participate in ongoing trials.

Note:Becoming knowledgeable and informed is a first step when considering participation in a clinical trial. These additional resources for patients and caregivers may help you.

- Data suggest that MAVENCLAD(TM) (Cladribine Tablets) selectively and discontinuously reduces B and T lymphocytes, with lymphocyte counts returning to normal range before the end of Year 2 - The lymphocyte data presented at EAN Congress are consistent with other clinical safety presentations of MAVENCLAD(TM) (Cladribine Tablets) at the congress.

Merck, a leading science and technology company, today announced the presentation of safety and efficacy data on MAVENCLAD(TM) (Cladribine Tablets) for the treatment of relapsing MS at the 3rd Congress of the European Association of Neurology (EAN), in Amsterdam, the Netherlands. Data from the placebo-controlled CLARITY, CLARITY Extension and ORACLE-MS clinical trials support the benefit: risk profile of Cladribine Tablets that have prompted an application for marketing authorisation in the EU, and the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

About MAVENCLAD(TM) (Cladribine Tablets) - Cladribine Tablets is a short-course oral therapy that is believed to selectively and periodically target lymphocytes thought to be integral to the pathological process of MS. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada and Europe. In June 2017, the Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the use of Cladribine Tablets for highly active relapsing MS, and this recommendation has been passed on to the EC to make the final decision on the Marketing Authorization Application (MAA) later this year.

In these studies, Cladribine Tablets was administered as two annual treatment courses in Years 1 and 2, with a total maximum of 20 days of oral treatment equal to a dose of 3.5 mg/kg body weight, followed by no further active treatment in Years 3 and 4.

"These data presented at EAN Congress 2017 bring the MS treating community closer to understanding the mechanism of action of Cladribine Tablets," said Professor Per Soelberg SArensen, presenting author and Head of MS Research Unit, Danish Multiple Sclerosis Centre. "These data support the emerging theories around the ability of some agents to selectively 'reset' the immune system without the secondary autoimmunity that we sometimes see with treatments for relapsing MS. This would represent a significant advance in the field."

Data from three key studies suggest that Cladribine Tablets selectively and discontinuously reduce both B and T lymphocytes in patients with early and relapsing forms of MS. An early and discontinuous reduction of peripheral blood B cells was seen, with cells numbers reaching a nadir at 13 weeks after treatment, followed by a rapid reconstitution toward baseline. A moderate reduction in T cell counts was also shown, although to a lesser degree than B cells; this reduction was more pronounced in CD4+ than CD8+ lymphocytes.

An exploratory analysis of the CLARITY data suggests that if strict lymphocyte count rules are adhered to before each yearly short course treatment, then the proportion of patients recovering at the end of Year 1 was 89.1% and at the end of Year 2 was 88.3%. Given the clinical effect observed during Years 1 and 2 of dosing in CLARITY, and beyond Years 1 and 2 with CT 3.5 mg/kg in CLARITY EXT, these data demonstrate that the clinical effect observed is achieved without continuous immunosuppression and through selective effects on B and T cell populations.

"Following last week's positive CHMP opinion, this integrated safety data, including 8 years of follow up in some patients, further supports the use of Cladribine Tablets as a treatment option for patients with MS," said Luciano Rossetti, Global Head of R&D for the biopharma business of Merck.

On 23 June, the Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the use of Cladribine Tablets for relapsing MS, and this recommendation has been passed on to the European Commission (EC) to make the final decision on the Marketing Authorization Application (MAA) later this year.

Lymphopenia was the most commonly reported adverse event (AE) in patients treated with Cladribine Tablets. The incidence of infections was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1% and 99.0% rated mild-to-moderate by investigators.

MAVENCLAD(TM) is the proprietary name submitted to EMA for the investigational medicine Cladribine Tablets.

SYMPTOMS of MS

In multiple sclerosis , damage to the myelin in the central nervous system (CNS), and to the nerve fibers themselves, interferes with the transmission of nerve signals between the brain and spinal cord and other parts of the body. This disruption of nerve signals produces the primary symptoms of MS, which vary depending on where the damage has occurred.

Over the course of the disease, some symptoms will come and go, while others may be more lasting.

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